HIV-1 InfectionsPhase 4PREPPIENCT02593409
HIV PrEP Priming of Immune Effectors
A Phase 4 study testing TDF/FTC in people with HIV-1 Infections, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
Trial summary
Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one year. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1 Infections
- What is being tested?
- TDF/FTC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUganda
- Study dates
- 25 May 2017to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 at screening
- not intending to move away from the clinic's catchment area for the next 2 years
- HIV-1 antibody negative
- reports commercial sex work
- contact information is provided
- written informed consent
Who cannot join
- HIV infection at screening
- participation in previous or concurrent HIV vaccine trials
- lactating, pregnant or planning pregnancy
- renal function impairment (serum creatinine >1.5 mg/dl), Fanconi syndrome
- abnormal liver function tests (AST/ALT > 43 U/L), liver disease, viral hepatitis, hepatitis B virus (HBV) infection
- serum phosphorus <2.2mg/dl, osteoporosis
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- known sensitivity to components of the Truvada® formulation
- any immunosuppressive treatment, such as systemic corticosteroids
- assumption of medication that interacts with Truvada®
- high likelihood of poor adherence to PREP and clinic attendance
- any condition that in the opinion of the attending physician could endanger the health of the participant or render her unsuitable to participate in the trial
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
MRC/UVRI Uganda Research Unit on Aids - Good Health for Women Project
Kampala
Berna Kalanzi, 256417704000 ext. 157, Berna.Kalanzi@mrcuganda.org
Afusa Nabuuma, 256417704000 ext. 157, Afusa.Nabuuma@mrcuganda.org
About this study
Official title: HIV Pre-Exposure Prophylaxis Priming of Immune Effectors
Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one year.
Read the detailed description
Design This will be a single centre open label longitudinal observational trial. Women attending the "Good Health for Women" clinic will be informed about the objectives of the trial and volunteers able to provide informed consent and with high risk of exposure to HIV-1 determined by a sexual history questionnaire will be screened by Rapid antibody test. Seronegatives will be checked for eligibility by clinical examination and laboratory tests. The endpoint for enrolment will be 220 uninfected high risk participants.
Baseline blood samples will be obtained from participants at month 0. A monthly diary card will be provided for self documenting sexual exposure, alcohol use and pill taking. Participants will receive provisions of PrEP (tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) sufficient for one month, will be instructed on the daily prophylaxis and on how to record adherence on the diary card. Participants will be asked to return each month for treatment re-provisioning and a new card. The content of the diary card will be discussed in a short interview each month.
At month 6 and 12 blood samples will be collected for evaluating immune responses to HIV-1. Additional tests will be done for monitoring HIV-1 status, pregnancy and sexually transmitted infections (STIs). After month 12 PrEP will be discontinued (unless participants opt to continue PrEP until the end of the follow up) and all participants will provide blood samples at month 18.
Baseline and follow-up peripheral blood mononuclear cells (PBMC) samples will be compared for T cell responses to HIV by interferon-γ (IFN-γ) enzyme-linked immunospot (ELISPOT). In case of a positive immune response, plasma collected at the same time point will be nucleic acid test (NAT) tested to verify absence of HIV infection.
HIV infected participants will be evaluated for cluster of differentiation 4 (CD4) T cells and viral load and referred to a Care Program (PEPFAR).
At month 6, 12 and 18 in-depth interviews will be conducted with a randomly selected sample of 44 women (20 percent) to discuss facilitators and barriers to adherence. The diary answers will be tabulated to look for patterns and trends. A framework approach to analysis will be used for the analysis of the qualitative data from interviews.
- Conditions
- HIV-1 Infections
- Being tested
- TDF/FTC
- Keywords
- HIV-1, pre-exposure prophylaxis (PrEP), immune response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDF/FTCDrug
Also called Truvada®
All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| TDF/FTC | Other | All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months. Receives: Drug: TDF/FTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 12 months on PREP
Measured: 0-12 months
Secondary outcomes (2)
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 6 months on PREP
Measured: 0-6 months
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between 12 months on PREP and at 18 months after PREP cessation
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start25 May 2017
- Primary completionApr 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Pala, MD, Principal investigator, MRC/UVRI and LSHTM Uganda Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593409
- Sponsor's protocol ID
- PREPPIE001
- Acronym
- PREPPIE
- Status last verified
- Sep 2017
- First submitted
- 21 Oct 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cranage M, Sharpe S, Herrera C, Cope A, Dennis M, Berry N, Ham C, Heeney J, Rezk N, Kashuba A, Anton P, McGowan I, Shattock R. Prevention of SIV rectal transmission and priming of T cell responses in macaques after local pre-exposure application of tenofovir gel. PLoS Med. 2008 Aug 5;5(8):e157; discussion e157. doi: 10.1371/journal.pmed.0050157.
PubMed 18684007
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Pre-Exposure Prophylaxis Priming of Immune Effectors
- ClinicalTrials.gov ID
- NCT02593409
- Acronym / sponsor ID
- PREPPIE / PREPPIE001
- Conditions
- HIV-1 Infections
- Keywords
- HIV-1, pre-exposure prophylaxis (PrEP), immune response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research UnitUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one year.
Detailed description
Design This will be a single centre open label longitudinal observational trial. Women attending the "Good Health for Women" clinic will be informed about the objectives of the trial and volunteers able to provide informed consent and with high risk of exposure to HIV-1 determined by a sexual history questionnaire will be screened by Rapid antibody test. Seronegatives will be checked for eligibility by clinical examination and laboratory tests. The endpoint for enrolment will be 220 uninfected high risk participants.
Baseline blood samples will be obtained from participants at month 0. A monthly diary card will be provided for self documenting sexual exposure, alcohol use and pill taking. Participants will receive provisions of PrEP (tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) sufficient for one month, will be instructed on the daily prophylaxis and on how to record adherence on the diary card. Participants will be asked to return each month for treatment re-provisioning and a new card. The content of the diary card will be discussed in a short interview each month.
At month 6 and 12 blood samples will be collected for evaluating immune responses to HIV-1. Additional tests will be done for monitoring HIV-1 status, pregnancy and sexually transmitted infections (STIs). After month 12 PrEP will be discontinued (unless participants opt to continue PrEP until the end of the follow up) and all participants will provide blood samples at month 18.
Baseline and follow-up peripheral blood mononuclear cells (PBMC) samples will be compared for T cell responses to HIV by interferon-γ (IFN-γ) enzyme-linked immunospot (ELISPOT). In case of a positive immune response, plasma collected at the same time point will be nucleic acid test (NAT) tested to verify absence of HIV infection.
HIV infected participants will be evaluated for cluster of differentiation 4 (CD4) T cells and viral load and referred to a Care Program (PEPFAR).
At month 6, 12 and 18 in-depth interviews will be conducted with a randomly selected sample of 44 women (20 percent) to discuss facilitators and barriers to adherence. The diary answers will be tabulated to look for patterns and trends. A framework approach to analysis will be used for the analysis of the qualitative data from interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDF/FTC | Other | Drug: TDF/FTCAll participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥18 at screening
- not intending to move away from the clinic's catchment area for the next 2 years
- HIV-1 antibody negative
- reports commercial sex work
- contact information is provided
Key exclusion criteria (11 listed)
- HIV infection at screening
- participation in previous or concurrent HIV vaccine trials
- lactating, pregnant or planning pregnancy
- renal function impairment (serum creatinine >1.5 mg/dl), Fanconi syndrome
- abnormal liver function tests (AST/ALT > 43 U/L), liver disease, viral hepatitis, hepatitis B virus (HBV) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDF/FTCAlso: Truvada®All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months. | Drug | TDF/FTC |
Primary outcome
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 12 months on PREP
Time frame: 0-12 months
2 secondary outcomes
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 6 months on PREP
Time frame: 0-6 months
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between 12 months on PREP and at 18 months after PREP cessation
Time frame: 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Background: PubMed 18684007Cranage M, Sharpe S, Herrera C, Cope A, Dennis M, Berry N, Ham C, Heeney J, Rezk N, Kashuba A, Anton P, McGowan I, Shattock R. Prevention of SIV rectal transmission and priming of T cell responses in macaques after local pre-exposure application of tenofovir gel. PLoS Med. 2008 Aug 5;5(8):e157; discussion e157. doi: 10.1371/journal.pmed.0050157.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Pala, MD principal investigator
MRC/UVRI and LSHTM Uganda Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TDF/FTC in people with HIV-1 Infections, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berna Kalanzi (+256417704000 ext. 157, berna.kalanzi@mrcuganda.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 12 months on PREP (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02593409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.